Status:
RECRUITING
RC48 in Combination With AK104 and Bevacizumab in OCCC
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Ovary Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
Disitamab vedotin (RC48) in combination with AK104 (PD-1/CTLA-4 bispecific) and bevacizumab for the treatment of recurrent and persistent clear cell ovarian cancer: a single-arm, phase II, multicenter...
Detailed Description
Ovarian clear cell carcinoma (OCCC) ranks as the second most common epithelial ovarian malignancy in Asian women, characterized by extremely poor prognosis, with a median overall survival (OS) of 25.3...
Eligibility Criteria
Inclusion
- The pathological diagnosis confirms ovarian clear cell carcinoma. In cases of mixed carcinoma, a prerequisite is that clear cell carcinoma constitutes at least 70% of the tumor mass. Moreover, adherence to RECIST 1.1 criteria mandates the presence of at least one evaluable lesion.
- HER2 IHC ≥1+.
- Treatment-naïve individuals encompass those experiencing tumor progression during postoperative chemotherapy and those who, following platinum-containing neoadjuvant chemotherapy, have not undergone surgical intervention yet and subsequently manifested progression during or after platinum-containing chemotherapy, provided that they have received a maximum of 2 prior lines of chemotherapy.
- Recurrent patients, whether platinum-sensitive or platinum-resistant, include those lacking a platinum-free interval of ≥6 months and who, post-recurrence, have undergone re-administration of platinum-containing chemotherapy but have demonstrated an inability to tolerate toxic reactions, with a maximum of 2 lines of chemotherapy post-recurrence.
- Previous utilization of bevacizumab is permissible.
- Adequate bone marrow reserve function necessitates pre-operative blood routine parameters meeting specific criteria: white blood cell count ≥3.0×10\^9/L, neutrophil count ≥1.5×10\^9/L, platelet count ≥100×10\^9/L, and hemoglobin ≥80 g/L.
- atisfactory organ function entails biochemical test results within defined limits: AST ≤2.5× upper limit of normal (ULN), ALT ≤2.5× ULN, serum total bilirubin ≤1.5× ULN, and creatinine ≤1.5× ULN.
- ECOG performance status score ranging from 0 to 1.
- Patient participation is contingent upon voluntary execution of an informed consent form.
Exclusion
- Patients with a history of immunotherapy, including treatments targeting PD-1, PD-L1, CAR-T, and CTLA-4.
- Patients diagnosed with other malignancies within the past five years, excluding skin cancer and thyroid cancer.
- Patients with an expected survival of ≤12 weeks.
- Patients with a known allergy to taxane-based medications.
- Patients who, based on clinical assessment, have contraindications for receiving immunotherapy and/or bevacizumab, such as uncontrolled infections, gastrointestinal fistula, autoimmune diseases, active hepatitis, or active bleeding.
- Patients currently undergoing treatment with investigational anti-cancer drugs in other clinical trials.
- Patients with any unstable condition or situation that may compromise their safety or adherence to the study protocol.
Key Trial Info
Start Date :
September 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06540729
Start Date
September 24 2024
End Date
August 1 2030
Last Update
July 8 2025
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital
Guanzhou, Guangdong, China, 510120